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Orexin Antagonist
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose, 0.5 up to 312 hours postdose
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
Eligible Conditions
- Liver disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1: predose, 0.5 up to 312 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: predose, 0.5 up to 312 hours postdose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC(0-72 Hours): Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Postdose of Lemoborexant
AUC(0-8 Hours): Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Postdose of Lemoborexant
AUC(0-inf): Area Under Plasma Concentration Versus Time Curve From Time Zero to Infinity of Lemborexant
+2 moreSecondary study objectives
AUC(0-72 Hours): Area Under Plasma Concentration Versus Time Curve From Time Zero to 72 Hours Postdose of Lemborexant's Metabolites M4, M9, and M10
AUC(0-8 Hours): Area Under Plasma Concentration Versus Time Curve From Time Zero to 8 Hours Postdose of Lemborexant's Metabolites M4, M9, and M10
AUC(0-inf): Area Under Plasma Concentration Versus Time Curve From Time Zero to Inf Hours Postdose of Lemborexant's Metabolites M4, M9, and M10
+10 moreSide effects data
From 2018 Phase 3 trial • 1006 Patients • NCT027837295%
Headache
2%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run -in Period Placebo
Placebo
Zolpidem Tartrate Extended Release 6.25 mg
Lemborexant 5 mg
Lemborexant 10 mg
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: Healthy Participants (Control)Experimental Treatment1 Intervention
Healthy participants matched to participants with hepatic impairment in Cohorts A and B (matched with regards to age, sex, body mass index \[BMI\]) will receive a single 10 mg dose (1 × 10 mg lemborexant \[E2006\] tablet) in the morning with 240 mL of water following an overnight fast of at least 10 hours.
Group II: Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)Experimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single 10 mg dose (1 × 10 mg lemborexant \[E2006\] tablet) in the morning with 240 mL of water following an overnight fast of at least 10 hours.
Group III: Cohort A: Mild Hepatic Impairment (Child Pugh Class A)Experimental Treatment1 Intervention
Participants with mild hepatic impairment will receive a single 10 milligram (mg) dose (1 × 10 mg lemborexant \[E2006\] tablet) in the morning with 240 milliliters (mL) of water following an overnight fast of at least 10 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lemborexant
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
522 Previous Clinical Trials
160,611 Total Patients Enrolled
Purdue Pharma LPIndustry Sponsor
79 Previous Clinical Trials
15,771 Total Patients Enrolled